Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-27 @ 12:12 PM
Study NCT ID:
NCT02165657
Status:
WITHDRAWN
Last Update Posted:
2021-07-16
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Excimer Laser, Serum Markers & Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-21', 'size': 313051, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-12T09:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit participants into trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum inflammatory markers', 'timeFrame': '23 visits (~12 weeks)', 'description': 'Change in CRP, MPO, S100 and Resistin levels from screening to final visit.'}], 'secondaryOutcomes': [{'measure': 'Objective measure of hyperpigmentation', 'timeFrame': '23 visits (~12 weeks)', 'description': 'Chromameter Assessment to measure hyperpigmentation. L\\* values are measured with a chromameter. A lower L\\* means more hyperpigmentation.'}, {'measure': 'Objective measure of erythema', 'timeFrame': '23 visits (~12 weeks)', 'description': 'Chromameter Assessment to measure erythema. a\\* values are measured with a chromameter. A higher a\\* means more erythema.'}, {'measure': 'Improvement in Psoriasis based on PASI assessment', 'timeFrame': '23 visits (~12 weeks)', 'description': 'PASI will be performed throughout the study to assess response to treatment.'}, {'measure': 'Improvement in psoriasis based on PGA', 'timeFrame': '23 visits (~12 weeks)', 'description': 'PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Excimer laser', 'UVB', 'Psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.\n\nThe investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.', 'detailedDescription': 'Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Male or female with diagnosis of psoriasis\n* Psoriasis involvement of 5-15% BSA\n* Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks\n* Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks\n* Fitzpatrick Skin Types I-VI\n\nExclusion Criteria:\n\n* Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)\n* Any suspicion that the psoriasis is of the photosensitive variant.\n* Any medical condition that could be aggravated or may cause extreme discomfort during the study period.'}, 'identificationModule': {'nctId': 'NCT02165657', 'briefTitle': 'Excimer Laser, Serum Markers & Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis', 'orgStudyIdInfo': {'id': '06-13-33'}, 'secondaryIdInfos': [{'id': '06-13-33', 'type': 'OTHER', 'domain': 'Institutional Review Board (IRB) Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Excimer laser', 'description': 'Excimer laser treatment', 'interventionNames': ['Device: Excimer laser treatment']}], 'interventions': [{'name': 'Excimer laser treatment', 'type': 'DEVICE', 'description': 'Excimer laser irradiation twice a week for up to 20 treatments.', 'armGroupLabels': ['Excimer laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44077', 'city': 'Concord', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center (Concord Site)', 'geoPoint': {'lat': 39.02201, 'lon': -84.08021}}], 'overallOfficials': [{'name': 'Margaret Bobonich, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Photomedex', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Margaret Bobonich, NP', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}